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Verification of the differences of scoring effect in current scoring balloons

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Abstract

The characteristics of each scoring balloon seem to be different because material or configuration of scoring element in each device is unique. The aim of this study is to clarify the difference of scoring effect among 3 different scoring devices. We prepared 3 different scoring devices [Wolverine™ Cutting Balloon™ (CB), ScoreFlex™ NC (SF), NSE Alpha™ (NSE), n = 5 respectively. Balloon diameter is 3 mm and 2 types of silicone tubes with different elasticity [140 kPa (tube S) and 576 kPa (tube H), respectively. Inner diameter is 3 mm]. We dilated each balloon in each silicone tube with nominal pressure (NP) and 20 atmosphere (HP) and took a picture using a micro CT. We measured penetration depth of all scoring elements into silicone tube wall and calculated their percentage using the following formula; penetration depth/original scoring element height × 100. We also observed the deformation of scoring element during balloon inflation in each device. Scoring element of CB cut deeper into both tubes significantly than SF and NSE at both pressure (40.5% vs 25.1% and 16.8% at NP and 86.1% vs 33.5% and 29.1% at HP in tube S, p < 0.01, respectively, 62.6% vs 33.5% and 17.0% at NP and 93.3% vs 45.1% and 36.5% at HP in tube H, p < 0.01, respectively). Although no deformation of scoring element was recognized in CB, some deformations were observed in 50% of NSE and 40% of SF (p = 0.0377). Scoring balloon with sharp and firmly fixed scoring elements like CB may show definite scoring effect.

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Abbreviations

CB:

Cutting balloon

DCB:

Drug coated balloon

DES:

Drug eluting stent

HP:

High pressure

MFCT:

Micro focus computed tomography

NP:

Nominal pressure

NSE:

NSE Alpha

PCI:

Percutaneous coronary intervention

PD:

Penetration depth

SF:

ScoreFlex NC

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Acknowledgements

We thank Ryota Ito and Keisuke Murakami (both from Department of Modern Mechanical Engineering, Graduate School of Creative Science and Engineering, Waseda University) for their valuable help in data acquisition.

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Authors and Affiliations

  1. Department of Cardiology, Toyohashi Heart Center, 21-1 Gobutori, Oyamacho, Toyohashi, Aichi, 441-8530, Japan

    Yoshihisa Kinoshita & Takahiko Suzuki

  2. Cooperative Major in Advanced Biomedical Sciences, Joint Graduate School of Tokyo Women’s Medical University and Waseda University, Tokyo, Japan

    Kiyotaka Iwasaki

  3. Department of Modern Mechanical Engineering, School of Creative Science and Engineering, Waseda University, Tokyo, Japan

    Kiyotaka Iwasaki

Authors
  1. Yoshihisa Kinoshita
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  2. Kiyotaka Iwasaki
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  3. Takahiko Suzuki
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Correspondence to Yoshihisa Kinoshita.

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Conflict of interest

The Wolverine™ Cutting Balloon™ was supplied by Boston Scientific Japan and Lacrosse NSE Alpha™ was supplied by NIPRO and ScoreFlex™ NC was supplied by OrbusNeich Japan. Kinoshita Y has received speaker’s honoraria from TERUMO, KANEKA, ASAHI INTECC, Boston Scientific Japan, OrbusNeich Medical, Medtronic Japan and Abbott Vascular Japan. The other authors have no conflicts of interest to declare.

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Supplementary Information

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Movie1-4: The dilation of calcified vessel model by various devices. These movies show the scenes of dilation by various devices in calcified vessel model (thickness=400µm). Movie 1 was performed by non-compliant balloon, by ScoreFlexTM NC (SF) in Movie 2, by Lacrosse NSE AlphaTM(NSE) in Movie 3, and by WolverineTM Cutting BalloonTM (CB) in Movie 4. It looks that calcium tube was dilated explosively in Movie 1 to Movie 3 and their images are very similar. On the other hand, clear crack was able to see before dilation completely in M4 (MP4 491 kb)

Supplementary file2 (MP4 738 kb)

Supplementary file3 (MP4 749 kb)

Supplementary file4 (MP4 739 kb)

Movie 5 and 6: The OCT image during the dilation of calcified vessel model by Lacrosse NSE AlphaTM(NSE) and WolverineTM Cutting BalloonTM (CB). These movies were recorded by placing and activating only imaging core of optical coherence tomography catheter in the wire lumen of catheter. In Movie 5, only 2 cleavages were recognized after explosive expansion of calcified tube by NSE even though there were 3 elements on it. In Movie 6, 3 cleavages were recognized clearly after gradual expansion of calcified vessel model by CB (MP4 803 kb)

Supplementary file6 (MP4 598 kb)

Movie 7: Deformation of scoring element in NSE. A scoring element at 11 o’clock turned over in 8 seconds after balloon inflation. Another scoring element at 3 o’clock also turned over in 13 seconds after balloon inflation (MP4 4512 kb)

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Kinoshita, Y., Iwasaki, K. & Suzuki, T. Verification of the differences of scoring effect in current scoring balloons. Cardiovasc Interv and Ther 37, 513–518 (2022). https://doi.org/10.1007/s12928-021-00807-1

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  • DOI: https://doi.org/10.1007/s12928-021-00807-1

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